Trial · NCT01302899
To Study the Effects of Aliskiren on Albuminuria and Various Biomarkers in Patients With Nephropathy
NCT01302899, Phase 2, Terminated, Novartis Pharmaceuticals; results first posted 2013-01-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. To Study the Effects of Aliskiren on Albuminuria and Various Biomarkers in Patients With Nephropathy. Trials, record NCT01302899. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01302899
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Study the Effects of Aliskiren on Albuminuria and Various Biomarkers in Patients With Nephropathy
- NCT number
- NCT01302899
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Non-diabetic Nephropathy
- Interventions
- Aliskiren, Placebo to Aliskiren, Hydrochlorothiazide (HCTZ), Placebo to Hydrochlorothiazide (HCTZ), Ramipril
- First posted
- 2011-02-24
- Last updated
- 2013-01-30
- Other registries' IDs
- eudract:2009-012196-10
- Results first posted
- 2013-01-30
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Effect of Aliskiren on Albuminuria as Measured by Urinary Albumin Excretion Rate (UAER) | 26 weeks | Two 24-hour collections of urine were to be made at each study visit. The arithmetic mean of the two collections were planned to be used in the calculation of summary statistics and the statistical analyses. |
| Primary | Effect of Aliskiren on Albuminuria as Measured by Creatinine Indexed Albumin | 26 weeks | Two 24-hour collections of urine were to be made at each study visit. The arithmetic mean of the two collections were planned to be used in the calculation of summary statistics and the statistical analyses. |
| Secondary | Mean Sitting Systolic Blood Pressure (msSBP) | 26 weeks | At study entry, blood pressure (BP) was measured in both arms. If there was a clinically relevant difference in readings between arms (≥ 10 mmHg in systolic BP and/or ≥ 5 mmHg in diastolic BP), the arm with higher BP reading was used. If there was no clinically significant difference between arms, the non-dominant arm was used through out study. Systolic blood pressure were assessed after the patient rested quietly in the sitting position for at least 3 minutes. For each sitting assessment, blood pressure was assessed at least 3 times. From these assessments, msSBP was calculated. All BP measurements were to be performed on the same arm. |
| Secondary | Mean Sitting Diastolic Blood Pressure (msDBP) | 26 weeks | At study entry, blood pressure (BP) was measured in both arms. If there was a clinically relevant difference in readings between arms (≥ 10 mmHg in systolic BP and/or ≥ 5 mmHg in diastolic BP), the arm with higher BP reading was used. If there was no clinically significant difference between arms, the non-dominant arm was used through out study. Diastolic blood pressure were assessed after the patient rested quietly in the sitting position for at least 3 minutes. For each sitting assessment, blood pressure was assessed at least 3 times. From these assessments, msDBP was calculated. All BP measurements were to be performed on the same arm. |
| Secondary | Mean Glomerular Filtration Rate (GFR) as Measurement of Renal Function | 26 weeks | All patients had to visit the main center for renal function measurements. The measurements were performed using the constant infusion method with I-iothalamate (IOT) and I-hippuran. GFR was calculated as the urinary clearance of IOT. |
| Secondary | Mean Effective Renal Plasma Flow (ERPF) as One of Hemodynamic Assessments | 26 weeks | |
| Secondary | Percentage of Renal Filtration Fraction (RFF) as One of Hemodynamic Assessments | 26 weeks | |
| Secondary | Mean Extracellular Volume (ECV) as One of Hemodynamic Assessments | 26 weeks | |
| Secondary | Plasma Rennin Activity (PRA) | Baseline to week 26 | Blood biomarkers were obtained from blood samples in all patients at the time points such as baseline, week 6, week 12, week 18 and week 26. Plasma PRA is a direct measure of the formation of Ang I in the plasma. |
| Secondary | Plasma Rennin Concentration (PRC) | Baseline to week 26 | Blood biomarkers were obtained from blood samples in all patients at the time points such as baseline, week 6, week 12, week 18 and week 26. PRC measures the concentration of immunoactive renin in the plasma. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Effect of Aliskiren on Albuminuria as Measured by Urinary Albumin Excretion Rate (UAER) | 26 weeks | The study was terminated and consequentially was underpowered for adequate statistical analysis | ||
| PRIMARY | Effect of Aliskiren on Albuminuria as Measured by Creatinine Indexed Albumin | 26 weeks | The study was terminated and consequentially was underpowered for adequate statistical analysis | ||
| SECONDARY | Mean Sitting Systolic Blood Pressure (msSBP) | 26 weeks | The study was terminated and consequentially was underpowered for adequate statistical analysis | ||
| SECONDARY | Mean Sitting Diastolic Blood Pressure (msDBP) | 26 weeks | The study was terminated and consequentially was underpowered for adequate statistical analysis | ||
| SECONDARY | Mean Glomerular Filtration Rate (GFR) as Measurement of Renal Function | 26 weeks | The study was terminated and consequentially was underpowered for adequate statistical analysis | ||
| SECONDARY | Mean Effective Renal Plasma Flow (ERPF) as One of Hemodynamic Assessments | 26 weeks | The study was terminated and consequentially was underpowered for adequate statistical analysis | ||
| SECONDARY | Percentage of Renal Filtration Fraction (RFF) as One of Hemodynamic Assessments | 26 weeks | The study was terminated and consequentially was underpowered for adequate statistical analysis | ||
| SECONDARY | Mean Extracellular Volume (ECV) as One of Hemodynamic Assessments | 26 weeks | The study was terminated and consequentially was underpowered for adequate statistical analysis | ||
| SECONDARY | Plasma Rennin Activity (PRA) | Baseline to week 26 | The study was terminated and consequentially was underpowered for adequate statistical analysis | ||
| SECONDARY | Plasma Rennin Concentration (PRC) | Baseline to week 26 | The study was terminated and consequentially was underpowered for adequate statistical analysis |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events, Serious Adverse Events and Death as Assessment of Safety and Tolerability of Aliskiren Added to Ramipril | Ramipril +HCTZ | patients with adverse events | 7 | Participants | |
| Number of Participants With Adverse Events, Serious Adverse Events and Death as Assessment of Safety and Tolerability of Aliskiren Added to Ramipril | Ramipril+Aliskiren + HCTZ | patients with adverse events | 5 | Participants | |
| Number of Participants With Adverse Events, Serious Adverse Events and Death as Assessment of Safety and Tolerability of Aliskiren Added to Ramipril | Ramipril+Aliskiren | patients with adverse events | 3 | Participants | |
| Number of Participants With Adverse Events, Serious Adverse Events and Death as Assessment of Safety and Tolerability of Aliskiren Added to Ramipril | Ramipril | patients with adverse events | 4 | Participants | |
| Number of Participants With Adverse Events, Serious Adverse Events and Death as Assessment of Safety and Tolerability of Aliskiren Added to Ramipril | Ramipril +HCTZ | patients with serious adverse events | 0 | Participants | |
| Number of Participants With Adverse Events, Serious Adverse Events and Death as Assessment of Safety and Tolerability of Aliskiren Added to Ramipril | Ramipril+Aliskiren + HCTZ | patients with serious adverse events | 0 | Participants | |
| Number of Participants With Adverse Events, Serious Adverse Events and Death as Assessment of Safety and Tolerability of Aliskiren Added to Ramipril | Ramipril+Aliskiren | patients with serious adverse events | 0 | Participants | |
| Number of Participants With Adverse Events, Serious Adverse Events and Death as Assessment of Safety and Tolerability of Aliskiren Added to Ramipril | Ramipril | patients with serious adverse events | 0 | Participants | |
| Number of Participants With Adverse Events, Serious Adverse Events and Death as Assessment of Safety and Tolerability of Aliskiren Added to Ramipril | Ramipril +HCTZ | patients with death | 0 | Participants | |
| Number of Participants With Adverse Events, Serious Adverse Events and Death as Assessment of Safety and Tolerability of Aliskiren Added to Ramipril | Ramipril+Aliskiren + HCTZ | patients with death | 0 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 (Day 1 to End of Week 6) | STARTED | Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram | 4 | |
| Period 1 (Day 1 to End of Week 6) | STARTED | Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram | 4 | |
| Period 1 (Day 1 to End of Week 6) | COMPLETED | Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram | 4 | |
| Period 1 (Day 1 to End of Week 6) | COMPLETED | Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram | 4 | |
| Period 1 (Day 1 to End of Week 6) | NOT COMPLETED | Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram | 0 | |
| Period 1 (Day 1 to End of Week 6) | NOT COMPLETED | Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram | 0 | |
| Period 2 (Weeks 7 to 12) | STARTED | Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram | 4 | |
| Period 2 (Weeks 7 to 12) | STARTED | Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram | 4 | |
| Period 2 (Weeks 7 to 12) | COMPLETED | Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram | 3 | |
| Period 2 (Weeks 7 to 12) | COMPLETED | Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram | 3 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events112
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Ramipril +HCTZ | 3 | 8 | |
| other | Fatigue | General disorders | Ramipril+Aliskiren + HCTZ | 2 | 7 | |
| other | Fatigue | General disorders | Ramipril+Aliskiren | 2 | 7 | |
| other | Fatigue | General disorders | Ramipril | 2 | 6 | |
| other | Dizziness | Nervous system disorders | Ramipril +HCTZ | 4 | 8 | |
| other | Dizziness | Nervous system disorders | Ramipril+Aliskiren + HCTZ | 2 | 7 | |
| other | Dizziness | Nervous system disorders | Ramipril+Aliskiren | 0 | 7 | |
| other | Dizziness | Nervous system disorders | Ramipril | 0 | 6 | |
| other | Muscle spasms | Musculoskeletal and connective tissue disorders | Ramipril +HCTZ | 3 | 8 | |
| other | Muscle spasms | Musculoskeletal and connective tissue disorders | Ramipril+Aliskiren + HCTZ | 0 | 7 |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ramipril +HCTZ | ||
| Total, all-cause mortality | Ramipril+Aliskiren + HCTZ | ||
| Total, all-cause mortality | Ramipril+Aliskiren | ||
| Total, all-cause mortality | Ramipril | ||
| Total, other adverse events | Ramipril +HCTZ | 7 | 8 |
| Total, other adverse events | Ramipril+Aliskiren + HCTZ | 5 | 7 |
| Total, other adverse events | Ramipril+Aliskiren | 3 | 7 |
| Total, other adverse events | Ramipril | 4 | 6 |
| Total, serious adverse events | Ramipril +HCTZ | 0 | 8 |
| Total, serious adverse events | Ramipril+Aliskiren + HCTZ | 0 | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01302899
GET https://conductscience.org/api/trials/v1/NCT01302899/flow?page=2